title: Feasibility of 6-month maintenance cetuximab after adjuvant concurrent chemoradiation plus cetuximab in squamous cell carcinoma of the head and neck.
abstract: BACKGROUND
  Close resection margins < 5 mm (CM) or extra capsular extent at the lymph nodes (ECE) impair the prognosis of patients with squamous cell cancer of the head and neck (SCCHN) scheduled for adjuvant radiochemotherapy. We conducted a multicenter phase II study to investigate toxicity and efficacy of additional cetuximab administered concomitantly and as maintenance for the duration of 6 months following adjuvant radiochemotherapy., Ppreliminary results on feasibility and acute toxicity on skin and mucosa are presented in this article.
  
  
  METHODS
  Patients with SCCHN following CM resection or with ECE were eligible for the study. In all, 61.6 Gy (1.8/2.0/2.2 Gy, days 1-36) were administered using an integrated boost intensity-modulated radiotherapy (IMRT) technique. Cisplatin (20 mg/m(2), days 1-5 and days 29-33) and 5-fluorouracil (5-FU) as continuous infusion (600 mg/m(2), days 1-5 + days 29-33) were given concurrently. Cetuximab was started 7 days prior to radiochemotherapy at 400 mg/m(2) followed by weekly doses of 250 mg/m(2). Maintenance cetuximab began after radiochemotherapy at 500 mg/m(2) every 2 weeks for 6 months.
  
  
  RESULTS
  Of the 55 patients (46 male, 9 female, mean age 55.6, range 29-70 years) who finished radiochemotherapy, 50 were evaluable for acute toxicity concerning grade III/IV toxicities of skin and mucosa. Grade 3-4 (CTC 3.0) mucositis, radiation dermatitis, and skin reactions outside the radiation portals were documented for 46, 28, and 14 % of patients, respectively. One toxic death occurred (peritonitis at day 57). Cetuximab was terminated in 5 patients due to allergic reactions after the first application. In addition, 22 % of patients discontinued cetuximab within the last 2 weeks or at the end of radiochemotherapy. Of patients embarking on maintenance treatment, 80 % were still on cetuximab at 3 months and 63 % at 5 months. Concurrent and maintenance treatment with cetuximab could be administered as scheduled in 48 % of patients.
  
  
  CONCLUSIONS
  Adjuvant radiochemotherapy with concomitant and maintenance cetuximab is feasible and acute toxicities are within the expected range. Compliance within the first 3-5 months is moderate.
authors.affiliation: Medical Faculty, Department of Radiation Oncology, Heinrich Heine University of Düsseldorf, Moorenstr. 5, 40225, Düsseldorf, Germany.
authors.forename: C
authors.initials: C
authors.lastname: Matuschek
authors.forename: E
authors.initials: E
authors.lastname: Bölke
authors.forename: C
authors.initials: C
authors.lastname: Belka
authors.forename: U
authors.initials: U
authors.lastname: Ganswindt
authors.forename: M
authors.initials: M
authors.lastname: Henke
authors.forename: P
authors.initials: P
authors.lastname: Stegmaier
authors.forename: M
authors.initials: M
authors.lastname: Bamberg
authors.forename: S
authors.initials: S
authors.lastname: Welz
authors.forename: J
authors.initials: J
authors.lastname: Debus
authors.forename: A
authors.initials: A
authors.lastname: Gioules
authors.forename: A
authors.initials: A
authors.lastname: Voigt
authors.forename: G
authors.initials: G
authors.lastname: Volk
authors.forename: C
authors.initials: C
authors.lastname: Ohmann
authors.forename: T
authors.initials: T
authors.lastname: Wiegel
authors.forename: V
authors.initials: V
authors.lastname: Budach
authors.forename: M
authors.initials: M
authors.lastname: Stuschke
authors.forename: J
authors.initials: J
authors.lastname: Schipper
authors.forename: P A
authors.initials: PA
authors.lastname: Gerber
authors.forename: W
authors.initials: W
authors.lastname: Budach
mesh_terms: D000328:Adult; D000368:Aged; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage*; D000970:Antineoplastic Agents / Q000008:administration & dosage; D002294:Carcinoma, Squamous Cell / Q000628:therapy*; D000068818:Cetuximab; D059248:Chemoradiotherapy / Q000009:adverse effects / Q000379:methods*; D005240:Feasibility Studies; D005260:Female; D006258:Head and Neck Neoplasms / Q000628:therapy*; D006801:Humans; D008137:Longitudinal Studies; D060046:Maintenance Chemotherapy / Q000379:methods*; D008297:Male; D008875:Middle Aged; D011832:Radiation Injuries / Q000175:diagnosis / Q000209:etiology*; D020266:Radiotherapy, Conformal / Q000009:adverse effects*; D016896:Treatment Outcome
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D000970:Antineoplastic Agents; D000068818:Cetuximab